California Healthcare Institute

CHI-California Healthcare Institute is a private, non-profit public policy research and advocacy organization, representing more than 250 universities, academic research centers, biotechnology, and medical device companies. Founded in 1993, and based in La Jolla, California, CHI has offices in Washington, D.C., and Sacramento, California. CHI publishes an annual California Biomedical Industry report, providing data on the scope and scale of academic and commercial life sciences research and development within the state. In 2008, the industry employed more than 270,000 Californians and produced revenues in excess of $75 billion.

FDA device approval reform
CHI published a study, Competitiveness and Regulation: The FDA and the Future of America’s Biomedical Industry, which concluded that device approval times had increased, that approval times in the European Union were faster than those in the U.S., and that "inefficiency at the FDA had resulted in American inventions made available to patients and physicians in other countries first ... [and] has pushed jobs and revenues offshore."

This report was presented at an oversight hearing of the House of Representatives, Committee on Energy and Commerce, on FDA medical device regulation.

The report defended the expedited approval process for devices and said that "Devices, in contrast, may be altered in minor ways -- switching to a new metal alloy, installing a longer-lasting battery, using a better polymer -- so that the effects on the product's safety and efficacy profile are predictable."

The Democratic members of the committee submitted the report to editors of major peer-reviewed journals for evaluation.

CHI Board of Directors
CHI's Chairman is Carl Hull, president and chief executive officer, Gen-Probe, Inc.; its President and CEO is David Gollaher.

Board members include: Susan M. Baxter, Ph.D., executive director, California State University

David W. Beier, senior vice president, global government affairs and corporate affairs, Amgen

Ken Berger, president, specialty diagnostics business, Thermo Fisher Scientific

Michael V. Drake, M.D., chancellor, University of California, Irvine

John M. Dunn, executive vice president, new ventures, Biogen Idec

Peter C. Farrell, Ph.D., DSc, AM, executive chairman of the board, ResMed

David D. Fleming, group senior vice president and corporate officer, Genzyme Corporation

Michael A. Friedman, M.D., president and CEO, City of Hope

Robert B. Hance, president, Abbott Vascular

Paul Hastings, president and chief executive officer, OncoMed Pharmaceuticals;

Terry Hermiston, Ph.D., vice president, U.S. Biologics Research Site Head, U.S. Innovation Center, Bayer Healthcare Pharmaceuticals

Steve Krognes, senior vice president and chief financial officer, Genentech

Peter Barton Hutt, partner, Covington & Burling

Tracy T. Lefteroff, National Life Sciences Partner, PricewaterhouseCoopers

Marcea B. Lloyd, senior vice president, government and corporate affairs and general counsel, Amylin Pharmaceuticals

John C. Martin, Ph.D., chairman of the board and CEO, Gilead Sciences

Dana G. Mead Jr., partner, Kleiner Perkins Caufield & Byers

Peter G. Milner, M.D., president, co-founder, member board of directors, ARYx Therapeutics, Inc.

Michael A. Mussallem, chairman and CEO, Edwards Lifesciences

Christian W. Nolet, partner and life sciences leader, west region, Ernst & Young

Michael Onuscheck, president and senior vice president, neuromodulation, Boston Scientific

Richard P. Patrylak, senior vice president, customer sales, marketing and policy, Merck & Company

David E.I. Pyott, chairman of the board and CEO, Allergan

William E. Rhodes, worldwide president, BD Biosciences

John D. Stobo, M.D., senior vice president for health sciences and services, University of California

Katie M. Szyman, senior vice president and president, diabetes, Medtronic Diabetes

Eric J. Topol, director, Scripps Translational Science Institute; chief academic officer, Scripps Health; vice chairman, West Wireless Health Institute

Keith C. Valentine, president and COO, NuVasive, Inc.

CHI Membership Members include the University of California, Amgen, University of California, Irvine, Biogen Idec, Stanford, Amgen, Genentech and Gilead Sciences.